CN1206267C - Film coatings and film coating compositions based on polyvinyl alcohol - Google Patents
Film coatings and film coating compositions based on polyvinyl alcohol Download PDFInfo
- Publication number
- CN1206267C CN1206267C CNB008100950A CN00810095A CN1206267C CN 1206267 C CN1206267 C CN 1206267C CN B008100950 A CNB008100950 A CN B008100950A CN 00810095 A CN00810095 A CN 00810095A CN 1206267 C CN1206267 C CN 1206267C
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- fluid film
- film dressing
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- 239000000203 mixture Substances 0.000 title claims abstract description 81
- 239000004372 Polyvinyl alcohol Substances 0.000 title claims abstract description 72
- 229920002451 polyvinyl alcohol Polymers 0.000 title claims abstract description 72
- 239000007888 film coating Substances 0.000 title claims abstract description 44
- 238000009501 film coating Methods 0.000 title claims abstract description 44
- 239000006185 dispersion Substances 0.000 claims abstract description 88
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 51
- 239000000049 pigment Substances 0.000 claims abstract description 46
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims abstract description 42
- 238000000576 coating method Methods 0.000 claims abstract description 32
- 239000011248 coating agent Substances 0.000 claims abstract description 28
- 238000000034 method Methods 0.000 claims abstract description 25
- 235000011187 glycerol Nutrition 0.000 claims abstract description 21
- 235000009508 confectionery Nutrition 0.000 claims abstract description 10
- 235000015872 dietary supplement Nutrition 0.000 claims abstract description 10
- 235000013305 food Nutrition 0.000 claims abstract description 10
- 238000002156 mixing Methods 0.000 claims abstract description 7
- 238000001035 drying Methods 0.000 claims abstract description 3
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims description 82
- 239000012530 fluid Substances 0.000 claims description 71
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims description 41
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 claims description 41
- -1 polyoxyethylene Polymers 0.000 claims description 41
- 239000000470 constituent Substances 0.000 claims description 39
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 claims description 31
- 230000007062 hydrolysis Effects 0.000 claims description 26
- 238000006460 hydrolysis reaction Methods 0.000 claims description 26
- 239000004902 Softening Agent Substances 0.000 claims description 20
- 229920002689 polyvinyl acetate Polymers 0.000 claims description 14
- 239000011118 polyvinyl acetate Substances 0.000 claims description 14
- 239000011159 matrix material Substances 0.000 claims description 10
- 229920001223 polyethylene glycol Polymers 0.000 abstract description 17
- 239000000758 substrate Substances 0.000 abstract description 5
- IIZPXYDJLKNOIY-JXPKJXOSSA-N 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/CCCCC IIZPXYDJLKNOIY-JXPKJXOSSA-N 0.000 abstract 2
- 239000002202 Polyethylene glycol Substances 0.000 abstract 2
- 235000010445 lecithin Nutrition 0.000 abstract 2
- 229940067606 lecithin Drugs 0.000 abstract 2
- 239000000787 lecithin Substances 0.000 abstract 2
- 239000003605 opacifier Substances 0.000 abstract 2
- 239000004014 plasticizer Substances 0.000 abstract 2
- 239000000454 talc Substances 0.000 abstract 2
- 229910052623 talc Inorganic materials 0.000 abstract 2
- 239000010408 film Substances 0.000 description 40
- 239000003826 tablet Substances 0.000 description 24
- 239000007921 spray Substances 0.000 description 9
- 239000000126 substance Substances 0.000 description 8
- 238000005507 spraying Methods 0.000 description 7
- 230000002045 lasting effect Effects 0.000 description 6
- 239000012748 slip agent Substances 0.000 description 5
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 description 4
- 239000003795 chemical substances by application Substances 0.000 description 4
- 239000002198 insoluble material Substances 0.000 description 4
- 239000002245 particle Substances 0.000 description 4
- LOUPRKONTZGTKE-LHHVKLHASA-N quinidine Chemical compound C([C@H]([C@H](C1)C=C)C2)C[N@@]1[C@H]2[C@@H](O)C1=CC=NC2=CC=C(OC)C=C21 LOUPRKONTZGTKE-LHHVKLHASA-N 0.000 description 4
- 230000005540 biological transmission Effects 0.000 description 3
- 239000003814 drug Substances 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 239000007787 solid Substances 0.000 description 3
- 230000015572 biosynthetic process Effects 0.000 description 2
- LOUPRKONTZGTKE-UHFFFAOYSA-N cinchonine Natural products C1C(C(C2)C=C)CCN2C1C(O)C1=CC=NC2=CC=C(OC)C=C21 LOUPRKONTZGTKE-UHFFFAOYSA-N 0.000 description 2
- 239000012153 distilled water Substances 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 238000005469 granulation Methods 0.000 description 2
- 230000003179 granulation Effects 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 229960001404 quinidine Drugs 0.000 description 2
- 239000002195 soluble material Substances 0.000 description 2
- 239000004408 titanium dioxide Substances 0.000 description 2
- JLPULHDHAOZNQI-ZTIMHPMXSA-N 1-hexadecanoyl-2-(9Z,12Z-octadecadienoyl)-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCCCCCC\C=C/C\C=C/CCCCC JLPULHDHAOZNQI-ZTIMHPMXSA-N 0.000 description 1
- BSYNRYMUTXBXSQ-UHFFFAOYSA-N Aspirin Chemical compound CC(=O)OC1=CC=CC=C1C(O)=O BSYNRYMUTXBXSQ-UHFFFAOYSA-N 0.000 description 1
- 206010009866 Cold sweat Diseases 0.000 description 1
- 229910010413 TiO 2 Inorganic materials 0.000 description 1
- 239000013543 active substance Substances 0.000 description 1
- 239000004411 aluminium Substances 0.000 description 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical group [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
- 229910052782 aluminium Inorganic materials 0.000 description 1
- 238000000889 atomisation Methods 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 239000000975 dye Substances 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000001704 evaporation Methods 0.000 description 1
- 230000008020 evaporation Effects 0.000 description 1
- 239000007941 film coated tablet Substances 0.000 description 1
- 239000000989 food dye Substances 0.000 description 1
- 235000011389 fruit/vegetable juice Nutrition 0.000 description 1
- 210000004051 gastric juice Anatomy 0.000 description 1
- 238000000227 grinding Methods 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- UQSXHKLRYXJYBZ-UHFFFAOYSA-N iron oxide Inorganic materials [Fe]=O UQSXHKLRYXJYBZ-UHFFFAOYSA-N 0.000 description 1
- 239000006186 oral dosage form Substances 0.000 description 1
- NDLPOXTZKUMGOV-UHFFFAOYSA-N oxo(oxoferriooxy)iron hydrate Chemical compound O.O=[Fe]O[Fe]=O NDLPOXTZKUMGOV-UHFFFAOYSA-N 0.000 description 1
- 239000003973 paint Substances 0.000 description 1
- 230000002572 peristaltic effect Effects 0.000 description 1
- 239000000902 placebo Substances 0.000 description 1
- 229940068196 placebo Drugs 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 238000005086 pumping Methods 0.000 description 1
- 238000005096 rolling process Methods 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 238000007614 solvation Methods 0.000 description 1
- 229940083466 soybean lecithin Drugs 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 239000000375 suspending agent Substances 0.000 description 1
- 239000010409 thin film Substances 0.000 description 1
- 230000007704 transition Effects 0.000 description 1
- 230000004584 weight gain Effects 0.000 description 1
- 235000019786 weight gain Nutrition 0.000 description 1
- 238000009736 wetting Methods 0.000 description 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08K—Use of inorganic or non-macromolecular organic substances as compounding ingredients
- C08K5/00—Use of organic ingredients
- C08K5/0008—Organic ingredients according to more than one of the "one dot" groups of C08K5/01 - C08K5/59
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08K—Use of inorganic or non-macromolecular organic substances as compounding ingredients
- C08K3/00—Use of inorganic substances as compounding ingredients
- C08K3/34—Silicon-containing compounds
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08K—Use of inorganic or non-macromolecular organic substances as compounding ingredients
- C08K5/00—Use of organic ingredients
- C08K5/49—Phosphorus-containing compounds
- C08K5/51—Phosphorus bound to oxygen
- C08K5/52—Phosphorus bound to oxygen only
- C08K5/521—Esters of phosphoric acids, e.g. of H3PO4
Landscapes
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Medicinal Chemistry (AREA)
- Polymers & Plastics (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- General Preparation And Processing Of Foods (AREA)
- Confectionery (AREA)
- Paints Or Removers (AREA)
Abstract
A dry film coating composition for use in coating pharmaceutical tablets, nutritional supplements, food, confectionery forms, agricultural seeds, and the like, comprises polyvinyl alcohol, a plasticizer such as polyethylene glycol or glycerin, talc, and preferably a pigment/opacifier and lecithin. A method of coating substrates such as pharmaceutical tablets, nutritional supplements, food, confectionery forms, agricultural seeds, and the like, with a film coating, comprises the steps of mixing polyvinyl alcohol, a plasticizer such as polyethylene glycol or glycerin, talc, and preferably a pigment/opacifier and lecithin into water to form an aqueous coating dispersion, applying an effective amount of said coating dispersion onto said substrates to form a film coating on said substrates, and drying the film coating on said substrates.
Description
Technical field
The present invention relates to the aqueous film dressing field such as matrix such as medicinal tablet, nutritional supplement, food, candy, agricultural seeds, particularly use is based on the dressing coated substrate of polyvinyl alcohol.
Background technology
Polyvinyl alcohol (PVA) polymkeric substance is suggested as film-coated application.But the practical application of this polymkeric substance is subjected to the restriction of its viscosity grade, and this polymkeric substance has solvability fast in cold water, and this point is used it in present aqueous film art for coating economical.
The U.S. Patent Application Serial Number 08/466 of Colorcon, 939 (is U.S. Patent number 5 at present, 885,617) a kind of moisture-proof film coated composition that is used for forming the moisture-proof film dressing on medicinal tablet is disclosed, this film coating composition contains polyvinyl alcohol, Yelkin TTS and optional glidant and/or tinting material and/or suspension agent, is incorporated herein this patent as a reference.This kind coated composition is by West Point, and the Colorcon of PA uses trade mark OPADRY AMB to sell.
OPADRY AMB coated composition forms the film coating with good moistureproofness.But, because PVA inherent viscosity, when on O ' the Hara Lab Coat I type dressing machine of 24 inches dishes that 12 kilograms of tablets are housed has been installed, using by the formed aqueous film dressing of OPADRY AMB coated composition solution/dispersion coating medicinal tablet, spray rate is on the low side (about 25-30 gram/minute, and the spraying system of other types can spray in the speed of 50-70 gram/minute).For the special applications that requires to use moisture-proof film dressing coating drug matrices, though low spray rate is disadvantageous, the humidity resistance that OPADRY AMB coated composition is obtained is more important than this deficiency.
For the use (for example, when not requiring humidity resistance) of common purpose, because the extra tooling cost that low spray rate is produced, low spray rate is unacceptable.
Polyoxyethylene glycol is a kind of known softening agent, is used for film coating and reduces the second-order transition temperature of film coating polymkeric substance and make the more non-friable of polymkeric substance.As the reckoning of Williams-Landel-Ferry equation, comprise in the coated systems that polyoxyethylene glycol should be able to make coated systems more tacky.Therefore, in very sticking PVA, add polyoxyethylene glycol and should be able to make coated systems more tacky, therefore, make the problem of viscosity of PVA more serious.
For the person of ordinary skill of the art, adding polyoxyethylene glycol in the film coating system can cause the reduction of film coating tensile strength also by universally recognized usually.Lower tensile strength means more easily broken film, and this is a defective.
And, for the person of ordinary skill of the art, also expect polyoxyethylene glycol and will damage the film-coated moistureproofness of PVA.
Usually use insoluble material, for example pigment, slip agents (glidant) and glidant in the film coating composition.For example, pigment is used to provide color to film coating, and talcum powder is used as slip agents and weighting material uses, to reduce the per-cent of other more expensive components in film coating composition.Using insoluble material in film coating composition may not be random, because as those skilled in the art extensively approval, in film coating composition, add insoluble material and can obviously reduce film-coated tensile strength, this means the increase along with soluble material quantity in the film coating, resulting film is cracky more.
People's such as Keith United States Patent (USP) 4,432,965 disclose a kind of oral dosage form of lasting release, this formulation comprises a tablet core that contains the quinidine of medicine effective quantity, and quinidine is by the polymeric dressing coating of the lasting release of the polyvinyl alcohol of a kind of polyoxyethylene glycol that contains the about 20 weight % of about 5 weight %-and about 80 weight %-95 weight %.PVA and polyoxyethylene glycol coating that people's such as Keith United States Patent (USP) 4,432,965 also discloses their lasting release are dissolved in gastric juice and intestinal juice slowly.
Summary of the invention
An object of the present invention is to provide a kind of coating based on polyvinyl alcohol, this coating has slick surface, shinny gloss, minimum viscosity, good film adhesivity and good tensile strength.
Another object of the present invention provides a kind of film coating based on polyvinyl alcohol, and this kind film coating can be on being sprayed on such as matrix such as medicinal tablet, nutritional supplement, food, candy, agricultural seeds under the dressing solution spraying speed of about 55-60 grams per minute.Another object of the present invention provides a kind of rapidly-soluble film coating.Invention by us realizes these and other purposes, hereinafter will describe the present invention in detail.
Embodiment
According to the present invention, the dry film dressing of the present invention that is used to apply medicinal tablet, nutritional supplement, food, candy, agricultural seed etc. comprises: (1) polyvinyl alcohol; (2) a kind of softening agent is as polyoxyethylene glycol or glycerine and (3) talcum powder.
Preferred dry film coated composition of the present invention comprises one or more following components: pigment/opalizer and Yelkin TTS.
According to the present invention, use the method for film coating coating such as matrix such as medicinal tablet, nutritional supplement, food, candy, agricultural seed to comprise the following steps: with (1) polyvinyl alcohol, (2) softening agent, in water, mix with (3) talcum powder as polyoxyethylene glycol or glycerine, form a kind of aqueous dressing dispersion, the dressing dispersion of significant quantity is coated on the matrix, on matrix, forms film coating, the film coating on the dry matrices.Can select but preferred one or more following components: pigment/opalizer and Yelkin TTS, in water, mix with polyvinyl alcohol, softening agent and talcum powder, form dressing dispersion of the present invention.
The present invention also comprises fluid film dressing dispersion, the matrix of coating, for example agricultural seed of the candy of the food of the nutritional supplement of coated drug tablet, coating, coating, coating, coating etc. and make the method for dry film coated composition and make the method for dressing dispersion of the present invention.
Polyvinyl alcohol (PVA) is the membrane-forming agent of this dressing.The grade of finding useful in the present invention polyvinyl alcohol is equivalent to contain the polyvinyl alcohol of the polyvinyl acetate of partial hydrolysis, and wherein the hydrolysis ratio of polyvinyl acetate is higher than about 86.5 moles of %, preferably in the scope of about 86.5-89.0 mole %.
Preferably with the polyvinyl alcohol micronization, when forming fluid film dressing solution, to promote the dissolving of polyvinyl alcohol in water.The size of particles of preferred micronized polyvinyl alcohol is descending number of columns and size range: 47.8% is higher than 200 microns; 28.7% between 200 microns and 145 microns; 22.9% between 145 microns and 100 microns; 0.5% between 100 microns and 80 microns; And 0.1% be lower than 80 microns.
Polyoxyethylene glycol is to make the softening agent that coating of the present invention is non-friable and be difficult for splitting.The polyoxyethylene glycol that has been found that nominal molecular weight 1000 to 20,000 is useful, and preferred molecular weight is higher than 3000 polyoxyethylene glycol.
Glycerine can replace polyoxyethylene glycol as another kind of softening agent.Ground beyond expectation, we find when being used for coated composition of the present invention, the film-coated viscosity of increase that glycerine does not have not only that as was expected, but reduced the film-coated viscosity that is obtained as a kind of slight release agent unexpectedly.
Talcum powder is a kind of slip agents, and the slickness of the final coating of talcum powder help raising, because talcum powder promotes mutual the rolling of tablet in coating process.Ground beyond expectation, based on the weight of coated composition, quantity is between about 9% to about 45%, and preferably approximately 9% is between about 20%, and more preferably about 10% talcum powder has improved film-coated tensile strength, obtains a kind of more blocky film.This is to find very unexpectedly, because on the estimation, along with insoluble component in the film coating composition, as the increase of talcum powder quantity, film-coated tensile strength will reduce.
Pigment/opalizer can be any authorized food dye, opalizer or dyestuff.For example, pigment/opalizer can be aluminium color lake, ferric oxide, titanium dioxide or natural pigment.Enumerate in the United States Patent (USP) 4,543,570 of the Colorcon that the example of this type of pigment/opalizer was awardd a certificate on September 24th, 1985, be incorporated herein this patent as a reference.
Yelkin TTS is a kind of release agent.We find: 1) by helping the component of wetting liquid body thin film dressing dispersion, Yelkin TTS also plays a role as tensio-active agent; Yelkin TTS helps the polyvinyl alcohol solvation; And by the moisture in the pinning dressing, thereby make dressing keep snappiness can't become frangible, Yelkin TTS has plasticization effect.
The scope of every kind of weight percentages of components is as follows in the dry film coated composition of the present invention:
Component
Acceptable scope (%)
Preferred range (%)
Polyvinyl alcohol 25-55 38-46
Polyoxyethylene glycol (or glycerine) 5-30 10-25
Talcum powder 9-45 9-20
Pigment/opalizer 0-40 20-30
Yelkin TTS 0-10 0-4
Embodiment
The following examples explanation the present invention.All units and ratio among the embodiment are all represented weight.
Embodiment 1
At a dry powder grinding machine, for example in the PK stirrer the dried component of following prescription was mixed 25 minutes or, obtain a kind of prescription of dry film coated composition of the present invention until obtaining uniform mixture.
Selectively, can use a kind of planetary-type mixer, for example special (Hobart) planetary-type mixer granulation of millibar dry film coated composition of the present invention.In mixing tank that the dry film coated composition is packed into and after opening mixing tank, the water that slowly adds capacity forms the particle that slightly is clamminess until said composition.Then with the sieve of these particles by a 1-2mm, drying is lower than 5% until moisture content in one 30 ℃ stove then.By the sieve screening composition of a 1-2mm, prepare to use with dustless particle form then once more.If do not carry out optionally granulation, for example can such as hammer mill (Apex, Machinery company, England, Dartford) in abrasive composition.Other operable granulating methods are spraying shotting and roll-in method.
The film coating composition that 300 grams are obtained is dispersed in the 1200 gram distilled water, form a kind of dressing dispersion of the present invention (20% solid content), use coating machine that 1500 this kind of gram dispersions are sprayed on 10 kilograms of tablets, formation has the coating of the present invention of 3% theoretical weight increment on tablet.Change the speed of rotation of (rpm) with per minute 12-14 and in coating machine, rotate tablet.The temperature of using the moisture in 60 ℃-70 ℃ the dressing dispersion of warm air evaporation spraying and keeping tablet is at 38 ℃-42 ℃.In coating process, the spray rate of dressing dispersion is per minute 60 grams.
After coating process was finished, tablet shows had the smooth surface that identifies content clearly.Film coating on the tablet has good lasting gloss, minimum viscosity, good film adhesivity and good tensile strength (approximately 10-15MPa)
Component
Ratio
Gram
Polyvinyl alcohol 44.00% 440.0
Talcum powder 20.00% 200.0
Pigment/opalizer 20.15% 201.5
PEG?3000 12.35％ 123.5
Yelkin TTS
03.50% 35.0
100.00％ 1000.0
Among the embodiment 2-16 below, mix according to the description of embodiment 1 component every kind of prescription, formation dressing solution also is coated on the tablet, acquisition has smooth surface, good lasting gloss, minimum viscosity, good film adhesivity and the film coating of good tensile strength, usually tensile strength at about 10MPa to approximately between the 16MPa.
Embodiment 2
Component
Ratio
Gram
Polyvinyl alcohol 44.00% 440.0
Talcum powder 20.00% 200.0
Titanium dioxide 20.15% 201.5
PEG?3000 12.35％ 123.5
Yelkin TTS
3.50% 35.0
100.00％ 1000.0
Embodiment 3
Component
Ratio
Gram
Polyvinyl alcohol 35.00% 350.0
Talcum powder 25.00% 250.0
Pigment/opalizer 29.00% 290.0
PEG?3000
11.00％ 110.0
100.00％ 1000.0
Embodiment 4
Component
Ratio
Gram
Polyvinyl alcohol 25.00% 250.0
Talcum powder 25.42% 254.2
Pigment/opalizer 27.08% 270.8
PEG?3000 17.08％ 170.8
Yelkin TTS
5.42% 54.2
100.00％ 1000.0
Embodiment 5
Component
Ratio
Gram
Polyvinyl alcohol 35.00% 350.0
Talcum powder 35.00% 350.0
PEG?3000 20.00％ 200.0
Yelkin TTS
10.00% 100.0
100.00％ 1000.0
Embodiment 6
Component
Ratio
Gram
Polyvinyl alcohol 44.00% 440.0
Talcum powder 18.35% 183.5
Pigment/opalizer 20.15% 201.5
PEG?3000 14.00％ 140.0
Yelkin TTS
3.50% 35.0
100.00％ 1000.0
Embodiment 7
Component
Ratio
Gram
Polyvinyl alcohol 44.00% 440.0
Talcum powder 20.00% 200.0
Pigment/opalizer 22.50% 225.0
PEG?3000 10.00％ 100.0
Yelkin TTS
3.50% 35.0
100.00％ 1000.0
Embodiment 8
Component
Ratio
Gram
Polyvinyl alcohol 44.00% 440.0
Talcum powder 20.00% 200.0
Pigment/opalizer 20.00% 200.0
PEG?3000 12.00％ 120.0
Yelkin TTS
4.00% 40.0
100.00％ 1000.0
Embodiment 9
Component
Ratio
Gram
Polyvinyl alcohol 44.65% 446.5
Talcum powder 20.00% 200.0
Pigment/opalizer 20.00% 200.0
PEG?3000
15.35％ 153.5
100.00％ 1000.0
Embodiment 10
Component
Ratio
Gram
Polyvinyl alcohol 44.00% 440.0
Talcum powder 20.00% 200.0
Pigment/opalizer 20.15% 201.5
PEG?3000 12.35％ 123.5
Yelkin TTS
3.50% 35.0
100.00％ 1000.0
Embodiment 11
Component
Ratio
Gram
Polyvinyl alcohol 44.00% 440.0
Talcum powder 10.00% 100.0
Pigment/opalizer 30.15% 301.5
PEG?3000 12.35％ 123.5
Yelkin TTS
3.50% 35.0
100.00％ 1000.0
Embodiment 12
Component
Ratio
Gram
Polyvinyl alcohol 46.00% 460.0
Talcum powder 18.00% 180.0
Pigment/opalizer 20.15% 201.5
PEG?3000 12.35％ 123.5
Yelkin TTS
3.50% 35.0
100.00％ 1000.0
Embodiment 13
Component
Ratio
Gram
Polyvinyl alcohol 38.00% 380.0
Talcum powder 20.00% 200.0
Pigment/opalizer 26.15% 261.5
PEG?3000 12.35％ 123.5
Yelkin TTS
3.50% 35.0
100.00％ 1000.0
Embodiment 14
Component
Ratio
Gram
Polyvinyl alcohol 44.00% 440.0
Talcum powder 10.15% 101.5
Pigment/opalizer 30.00% 300.0
PEG?3000 12.35％ 123.5
Yelkin TTS
3.50% 35.0
100.00％ 1000.0
Embodiment 15
Component
Ratio
Gram
Polyvinyl alcohol 44.63% 446.3
Talcum powder 19.85% 198.5
Pigment/opalizer 20.00% 200.0
PEG?3000 12.86％ 128.6
Yelkin TTS
2.66% 26.6
100.00％ 1000.0
Embodiment 16
Component
Ratio
Gram
Polyvinyl alcohol 47.65% 47.65
Talcum powder 19.67% 19.67
Soybean lecithin 6.33% 6.33
Glycerine 5.35% 5.35
TiO
2 2.31％ 2.31
FD﹠amp; No. 40 red color lakes of C 15.08% 15.08
FD﹠amp; No. 6 yellow lakes of C 3.41% 3.41
FD﹠amp; No. 2 blue looks of C color lake
0.20% 0.20
100.00％ 100.0
The dried component of above-mentioned prescription is added in the food-processor of appropriate size, effectively stir 5 minutes until evenly.After 5 minutes, in processing machine, add above-mentioned formulations of liquid part (glycerine, softening agent) and continue mixing 3 minutes, form dry film coated composition of the present invention.Be dispersed in 90 gram this kind preparations in the 360 gram distilled water then and stirred 45 minutes, form the solid content of preparing spraying and be 20.0% fluid film dressing dispersion.
One of the mixing tablet adding of 3.0 kg feed amounts is had in 15 inches O ' the Hara Labcoat I type coating pan of 4 mixing baffles and 6 antiskid bars 1.0 kilogram of 5 particulate Asprin nuclear core that tablet wherein contains the depression placebo of 2.0 kilograms of 3/8 inch standards and has similar size diameter.Use No. 1 paint finishing rifle (Spraying System Gun), 1/8VAU SS and a digital control peristaltic pump of Masterflex that has 17518-02 pumping head (pumphead) are sprayed on fluid film dressing dispersion on the tablet bed.In coating process, atomization air pressure is 25 pounds/square inch (psi), nozzle air (pattern air) pressure is 35psi, the intake air temperature is 70 ℃, outlet air temperature is 48 ℃, and the temperature of keeping the tablet bed is 41 ℃, and the dish rotating speed is 16rpm, the feeding rate of dressing liquid is 20 gram/minute (being equivalent to install the rotating speed of O ' the Hara Lab Coat I coating machine 50-60 gram/minute of 24 inches dishes), and the time of coating always is 22 minutes.Apply 3.0% theoretical dry coating weight gain and film coating on the tablet and had good lasting gloss, minimum viscosity, good adhesivity and good tensile strength (approximately 10-15MPa).
About the preparation of fluid film dressing dispersion of the present invention, also each component of coated composition of the present invention directly can be added in the entry, mix forming the dressing dispersion then.
The solid content of preferred prepared dressing dispersion is between 10%-30%.
We find that compare with the reckoning of William-Landel-Ferry equation, the film coating that our invention is produced has minimum viscosity.
We find, use fluid film dressing dispersion of the present invention can obtain the dressing solution spraying speed of about 60 gram/minute (in 24 inches dishes of 12 kilograms of tablets are housed).This is beyond expectation, because for the person of ordinary skill of the art, and known viscosity owing to polymkeric substance, very sticking polymkeric substance requires low spray rate.Therefore, as a kind of very sticking polymkeric substance, people may estimate that PVA requires low spray rate.For example, because the viscosity of PVA in the dressing solution, by the made low spray rate (for example, 24 inches dishes that 12 kilograms of tablets are housed are the 25-30 gram/minute) of dressing solution requirement of PVA base OPADRY AMB coated composition of Colorcon.
For the person of ordinary skill of the art, be generally acknowledged, for example in film coating composition, add insoluble material, can reduce film-coated tensile strength usually as pigment, slip agents and glidant.Surprisingly, we find to add soluble material talcum powder as slip agents and weighting agent in film coating composition of the present invention and film coating dispersion, improved film-coated tensile strength, and do not reduce film-coated tensile strength, wherein based on the weight of coated composition, adding talcous amount in film coating composition is that about 9 weight % are to about 45 weight %, preferably approximately 9 weight % to 20 weight %, more preferably at about 10 weight %, weight based on the non-water constituent of film coating dispersion, adding talcous amount in film coating dispersion of the present invention is that about 9 weight % are to about 45 weight %, preferably approximately 9 weight % to 20 weight %, more preferably about 10 weight %.Therefore,, can use talcum powder, therefore reduce the cost of film coating composition, and can be not cost to reduce film-coated tensile strength according to the reduction of PVA in film coating composition according to the present invention.
We find that also coating of the present invention has good humidity resistance.This point also is wondrous and beyong contemplation because polyoxyethylene glycol and similarly softening agent be hydrophilic and should reduce the humidity resistance of PVA.Though the film-coated water vapor transmission rate of being made by the OPADRY film coating composition that contains Vltra tears and polyoxyethylene glycol is about 40, and by the made film-coated water vapor transmission rate of OPADRY AMB coated composition that does not contain any polyoxyethylene glycol approximately is 6, but film-coated water vapor transmission rate constructed in accordance approximately is 10.
In addition, compare with the instruction of people's such as Keith United States Patent (USP) 4,432,965, we find to have applied the film-coated tablet of the present invention is rapidly-soluble.
Claims (54)
1. dry film coated composition that is used to apply medicinal tablet, nutritional supplement, food, candy or agricultural seed, it comprises
Polyvinyl alcohol, the content of this polyvinyl alcohol is in 25% to 55% scope of the weight of said composition;
Softening agent, this softening agent are polyoxyethylene glycol or glycerine; With
Talcum powder, this talcous content are 9% to 45% of said composition weight.
2. the described dry film coated composition of claim 1, polyvinyl alcohol wherein contains the polyvinyl acetate that the hydrolysis ratio is higher than the partial hydrolysis of 86.5 moles of %.
3. the described dry film coated composition of claim 1, polyvinyl alcohol wherein contains the polyvinyl acetate of the partial hydrolysis of hydrolysis ratio in 86.5-89.0 mole % scope.
4. the described dry film coated composition of claim 1, the content of polyvinyl alcohol wherein is in 38% to 46% scope of said composition weight.
5. the described dry film coated composition of claim 1, the molecular weight of polyoxyethylene glycol wherein is 1000 to 20,000.
6. the described dry film coated composition of claim 1, the molecular weight of polyoxyethylene glycol wherein is 3,000.
7. the described dry film coated composition of claim 1, the content of softening agent wherein is in 5% to 30% scope of said composition weight.
8. the described dry film coated composition of claim 1, the content of softening agent wherein is in 10% to 25% scope of said composition weight.
9. the described dry film coated composition of claim 1, talcous content wherein is in 9% to 20% scope of said composition weight.
10. the described dry film coated composition of claim 1, talcous content wherein is 10% of said composition weight.
11. the described dry film coated composition of claim 1 also comprises pigment/opalizer.
12. the described dry film coated composition of claim 11, the content of pigment/opalizer wherein is in 0% to 40% scope of said composition weight.
13. the described dry film coated composition of claim 11, the content of pigment/opalizer wherein is in 20% to 30% scope of said composition weight.
14. the described dry film coated composition of claim 1 also comprises Yelkin TTS.
15. the described dry film coated composition of claim 14, the content of Yelkin TTS wherein is in 0% to 10% scope of said composition weight.
16. the described dry film coated composition of claim 14, the content of Yelkin TTS wherein is in 0% to 4% scope of said composition weight.
17. the described dry film coated composition of claim 1, it also comprises pigment/opalizer and Yelkin TTS; Polyvinyl alcohol wherein contains the polyvinyl acetate that the hydrolysis ratio is higher than the partial hydrolysis of 86.5 moles of %; The molecular weight of polyoxyethylene glycol is 1000 to 20,000, and the content of polyoxyethylene glycol or glycerine is in 5% to 30% scope of said composition weight; The content of pigment/opalizer is in 0% to 40% scope of said composition weight; The content of Yelkin TTS is in 0% to 10% scope of said composition weight.
18. the described dry film coated composition of claim 1, it also comprises pigment/opalizer and Yelkin TTS; Polyvinyl alcohol wherein contains the polyvinyl acetate of the partial hydrolysis of hydrolysis ratio in 86.5-89.0 mole % scope, and the content of polyvinyl alcohol is in 38% to 46% scope of said composition weight; The molecular weight of polyoxyethylene glycol is 3,000, and the content of polyoxyethylene glycol or glycerine is in 10% to 25% scope of said composition weight; Talcous content is in 9% to 20% scope of said composition weight; The content of pigment/opalizer is in 20% to 30% scope of said composition weight; The content of Yelkin TTS is in 0% to 4% scope of said composition weight.
19. a fluid film dressing dispersion that is used to apply medicinal tablet, nutritional supplement, food, candy or agricultural seed, it comprises
Polyvinyl alcohol, the content of this polyalkenylalcohols is in 25% to 55% scope of the non-water constituent weight of this fluid film dressing dispersion;
Softening agent, this softening agent are polyoxyethylene glycol or glycerine;
Talcum powder, this talcous content is in 9% to 45% scope of the non-water constituent weight of this fluid film dressing dispersion; And
Water.
20. the described fluid film dressing of claim 19 dispersion, polyvinyl alcohol wherein contains the polyvinyl acetate that the hydrolysis ratio is higher than the partial hydrolysis of 86.5 moles of %.
21. the described fluid film dressing of claim 19 dispersion, polyvinyl alcohol wherein contain the polyvinyl acetate of the partial hydrolysis of hydrolysis ratio in 86.5-89.0 mole % scope.
22. the described fluid film dressing of claim 19 dispersion, the content of polyvinyl alcohol wherein is in 38% to 45% scope of the non-water constituent weight of this fluid film dressing dispersion.
23. the described fluid film dressing of claim 19 dispersion, the molecular weight of polyoxyethylene glycol wherein is 1000 to 20,000.
24. the described fluid film dressing of claim 19 dispersion, the molecular weight of polyoxyethylene glycol wherein is 3,000.
25. the described fluid film dressing of claim 19 dispersion, the polyoxyethylene glycol wherein or the content of glycerine are in 5% to 30% scope of the non-water constituent weight of this fluid film dressing dispersion.
26. the described fluid film dressing of claim 19 dispersion, the polyoxyethylene glycol wherein or the content of glycerine are in 10% to 25% scope of the non-water constituent weight of this fluid film dressing dispersion.
27. the described fluid film dressing of claim 19 dispersion, talcous content wherein is in 9% to 20% scope of the non-water constituent weight of this fluid film dressing dispersion.
28. the described fluid film dressing of claim 19 dispersion, talcous content wherein be this fluid film dressing dispersion non-water constituent weight 10%.
29. the described fluid film dressing of claim 19 dispersion also comprises the pigment/opalizer that is dispersed in the fluid film dressing dispersion.
30. the described fluid film dressing of claim 29 dispersion, the content of pigment/opalizer wherein is in 0% to 40% scope of the non-water constituent weight of this fluid film dressing dispersion.
31. the described fluid film dressing of claim 29 dispersion, the content of pigment/opalizer wherein is in 20% to 30% scope of the non-water constituent weight of this fluid film dressing dispersion.
32. the described fluid film dressing of claim 19 dispersion also comprises the Yelkin TTS that is dispersed in the fluid film dressing dispersion.
33. the described fluid film dressing of claim 32 dispersion, the content of Yelkin TTS wherein is in 0% to 10% scope of the non-water constituent weight of this fluid film dressing dispersion.
34. the described fluid film dressing of claim 32 dispersion, the content of Yelkin TTS wherein is in 0% to 4% scope of the non-water constituent of this fluid film dressing dispersion.
35. the described fluid film dressing of claim 19 dispersion, it also comprises pigment/opalizer and the Yelkin TTS that is dispersed in this fluid film dressing dispersion; Polyvinyl alcohol wherein contains the polyvinyl acetate that the hydrolysis ratio is higher than the partial hydrolysis of 86.5 moles of %; The molecular weight of polyoxyethylene glycol is 1000 to 20,000, and the content of polyoxyethylene glycol or glycerine is in 5% to 30% scope of the non-water constituent weight of this fluid film dressing dispersion; The content of pigment/opalizer is in 0% to 40% scope of the non-water constituent weight of this fluid film dressing dispersion; The content of Yelkin TTS is in 0% to 10% scope of the non-water constituent weight of this fluid film dressing dispersion.
36. the described fluid film dressing of claim 19 dispersion, it also comprises pigment/opalizer and the Yelkin TTS that is dispersed in this fluid film dressing dispersion; Polyvinyl alcohol wherein contains the polyvinyl acetate of the partial hydrolysis of hydrolysis ratio in 86.5-89.0 mole % scope, and the content of polyvinyl alcohol is in 38% to 46% scope of the non-water constituent weight of this fluid film dressing dispersion; The molecular weight of polyoxyethylene glycol is 3,000, and the content of polyoxyethylene glycol or glycerine is in 10% to 25% scope of the non-water constituent weight of this fluid film dressing dispersion; Talcous content is in 9% to 20% scope of the non-water constituent weight of this fluid film dressing dispersion; The content of pigment/opalizer is in 20% to 30% scope of the non-water constituent weight of this fluid film dressing dispersion; The content of Yelkin TTS is in 0% to 4% scope of the non-water constituent weight of this fluid film dressing dispersion.
37. a method of using the film coating coating to be selected from the matrix of medicinal tablet, nutritional supplement, food, candy or agricultural seed, this method comprises the following steps:
A kind of fluid film dressing dispersion will be formed in polyvinyl alcohol, softening agent and the talcum powder mixing entry, the content of polyvinyl alcohol is in 25% to 55% scope of the non-water constituent weight of this fluid film dressing dispersion, wherein softening agent is polyoxyethylene glycol or glycerine, and wherein talcous content is in 9% to 45% scope of the non-water constituent weight of fluid film dressing dispersion; Described dressing dispersion is administered on the described matrix, on described matrix, forms film coating; With the film coating on the described matrix of drying.
38. the described method of claim 37, wherein polyvinyl alcohol contains the polyvinyl acetate that the hydrolysis ratio is higher than the partial hydrolysis of 86.5 moles of %.
39. the described method of claim 37, wherein polyvinyl alcohol contains the polyvinyl acetate of the partial hydrolysis of hydrolysis ratio in 86.5-89.0 mole % scope.
40. the described method of claim 37, wherein the content of polyvinyl alcohol is in 38% to 46% scope of the non-water constituent weight of this fluid film dressing dispersion.
41. the described method of claim 37, softening agent wherein are molecular weight is 1000 to 20,000 polyoxyethylene glycol.
42. the described method of claim 37, softening agent wherein are molecular weight is 3,000 polyoxyethylene glycol.
43. the described method of claim 37, wherein, the content of this softening agent is in 5% to 30% scope of the non-water constituent weight of this fluid film dressing dispersion.
44. polyoxyethylene glycol or glycerine that the described method of claim 37, softening agent wherein are content in 10% to 25% scope of the non-water constituent weight of this fluid film dressing dispersion.
45. the described method of claim 37, talcous content wherein is in 9% to 20% scope of the non-water constituent weight of this fluid film dressing dispersion.
46. the described method of claim 37, talcous content wherein be this fluid film dressing dispersion non-water constituent weight 10%.
47. the described method of claim 37 wherein also comprises pigment/opalizer is dispersed in the fluid film dressing dispersion.
48. the described method of claim 47, the content of pigment/opalizer wherein is in 0% to 40% scope of the non-water constituent weight of this fluid film dressing dispersion.
49. the described method of claim 47, the content of pigment/opalizer wherein is in 20% to 30% scope of the non-water constituent weight of this fluid film dressing dispersion.
50. the described method of claim 37 wherein also comprises Yelkin TTS is dispersed in this fluid film dressing dispersion.
51. the described method of claim 50, the content of Yelkin TTS wherein is in 0% to 10% scope of the non-water constituent weight of this fluid film dressing dispersion.
52. the described method of claim 50, the content of Yelkin TTS wherein is in 0% to 4% scope of the non-water constituent weight of this fluid film dressing dispersion.
53. the described method of claim 37 wherein also comprises pigment/opalizer and Yelkin TTS are dispersed in this fluid film dressing dispersion; Polyvinyl alcohol wherein contains the polyvinyl acetate that the hydrolysis ratio is higher than the partial hydrolysis of 86.5 moles of %; The molecular weight of polyoxyethylene glycol is 1000 to 20,000, and the content of polyoxyethylene glycol or glycerine is in 5% to 30% scope of the non-water constituent weight of this fluid film dressing dispersion; The content of pigment/opalizer is in 0% to 40% scope of the non-water constituent weight of this fluid film dressing dispersion; The content of Yelkin TTS is in 0% to 10% scope of the non-water constituent weight of this fluid film dressing dispersion.
54. the described method of claim 37 wherein also comprises pigment/opalizer and Yelkin TTS are dispersed in this fluid film dressing dispersion; Polyvinyl alcohol wherein contains the polyvinyl acetate of the partial hydrolysis of hydrolysis ratio in 86.5-89.0 mole % scope, and the content of polyvinyl alcohol is in 38% to 46% scope of the non-water constituent weight of this fluid film dressing dispersion; The molecular weight of polyoxyethylene glycol is 3,000, and the content of polyoxyethylene glycol or glycerine is in 10% to 25% scope of the non-water constituent weight of this fluid film dressing dispersion; Talcous content is in 9% to 20% scope of the non-water constituent weight of this fluid film dressing dispersion; The content of pigment/opalizer is in 20% to 30% scope of the non-water constituent weight of this fluid film dressing dispersion; The content of Yelkin TTS is in 0% to 4% scope of the non-water constituent weight of this fluid film dressing dispersion.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US09/351,076 US6448323B1 (en) | 1999-07-09 | 1999-07-09 | Film coatings and film coating compositions based on polyvinyl alcohol |
| US09/351,076 | 1999-07-09 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1360612A CN1360612A (en) | 2002-07-24 |
| CN1206267C true CN1206267C (en) | 2005-06-15 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB008100950A Expired - Lifetime CN1206267C (en) | 1999-07-09 | 2000-06-30 | Film coatings and film coating compositions based on polyvinyl alcohol |
Country Status (20)
| Country | Link |
|---|---|
| US (1) | US6448323B1 (en) |
| EP (1) | EP1208143B1 (en) |
| JP (2) | JP2003509339A (en) |
| KR (1) | KR100616732B1 (en) |
| CN (1) | CN1206267C (en) |
| AR (1) | AR025542A1 (en) |
| AT (1) | ATE272674T1 (en) |
| AU (1) | AU766046B2 (en) |
| BR (1) | BR0012263B1 (en) |
| CA (1) | CA2374629C (en) |
| CO (1) | CO5190675A1 (en) |
| CZ (1) | CZ303912B6 (en) |
| DE (1) | DE60012754T2 (en) |
| EG (1) | EG24436A (en) |
| ES (1) | ES2225209T3 (en) |
| HU (1) | HU226963B1 (en) |
| IL (2) | IL147425A0 (en) |
| TW (1) | TWI288162B (en) |
| WO (1) | WO2001004195A1 (en) |
| ZA (1) | ZA200200104B (en) |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102421421A (en) * | 2009-05-12 | 2012-04-18 | Bpsi控股有限责任公司 | Film coatings containing fine particle size detackifiers and substrates coated therewith |
| CN107259580A (en) * | 2017-07-17 | 2017-10-20 | 武汉维奥制药有限公司 | The preparation method of one kind of multiple mineral matter vitamin preparations |
| CN107259580B (en) * | 2017-07-17 | 2018-06-19 | 武汉维奥制药有限公司 | The preparation method of one kind of multiple minerals vitamin preparations |
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| HUP0202260A2 (en) | 2002-11-28 |
| DE60012754D1 (en) | 2004-09-09 |
| IL147425A (en) | 2006-08-01 |
| IL147425A0 (en) | 2002-08-14 |
| KR20020029073A (en) | 2002-04-17 |
| US6448323B1 (en) | 2002-09-10 |
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| CZ200266A3 (en) | 2002-07-17 |
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| DE60012754T2 (en) | 2005-09-01 |
| CA2374629C (en) | 2009-05-19 |
| EP1208143B1 (en) | 2004-08-04 |
| AR025542A1 (en) | 2002-12-04 |
| TWI288162B (en) | 2007-10-11 |
| US20020103285A1 (en) | 2002-08-01 |
| EP1208143A1 (en) | 2002-05-29 |
| EP1208143A4 (en) | 2002-10-30 |
| BR0012263A (en) | 2002-03-12 |
| WO2001004195A1 (en) | 2001-01-18 |
| ES2225209T3 (en) | 2005-03-16 |
| KR100616732B1 (en) | 2006-08-28 |
| ZA200200104B (en) | 2003-06-25 |
| HU226963B1 (en) | 2010-03-29 |
| CZ303912B6 (en) | 2013-06-26 |
| WO2001004195A8 (en) | 2001-10-04 |
| CN1360612A (en) | 2002-07-24 |
| AU766046B2 (en) | 2003-10-09 |
| ATE272674T1 (en) | 2004-08-15 |
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